Study on Y-90, Capecitabine, and Atezolizumab for Treating Colorectal Cancer with Liver Metastases
Sponsor: Brown University
ClinicalTrials ID:NCT06555133
This clinical trial is testing a new treatment combination of Yttrium-90 radioembolization, capecitabine, and atezolizumab for patients with colorectal cancer that has spread to the liver and cannot be surgically removed. The study is for those who have already tried at least two other treatments.
Patient Parameters
| Parameter | Options |
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Program Overview
The purpose of this study is to evaluate the safety and effectiveness of a new treatment combination for colorectal cancer that has spread to the liver and cannot be removed by surgery. The treatment includes Yttrium-90 radioembolization, a type of radiation therapy, along with the chemotherapy drug capecitabine and the immunotherapy drug atezolizumab. This study is for patients who have already undergone at least two other systemic treatments for their cancer.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with colorectal cancer that has spread to the liver and cannot be surgically removed.
- Cancer must be measurable by scans and primarily located in the liver.
- Aged 18 years or older.
- In good general health, able to carry out daily activities with minimal restrictions.
- Cancer has progressed after trying at least two different treatments.
- Willing to provide tumor tissue and blood samples for research purposes.
- Less than 50% of the liver affected by cancer.
- Adequate blood, kidney, and liver function as shown by specific lab tests.
- Women of childbearing potential must use effective birth control during the study and for 6 months after.
- Men must use effective birth control during the study and for 3 months after.
- Able to understand and sign a consent form and follow study procedures.
Exclusion Criteria
- Previous treatment with Yttrium-90 or radiation to the liver.
- Life expectancy of less than 3 months.
- Certain genetic cancer markers or mutations.
- Cancer spread to the brain or abdomen, unless treated and stable.
- Recent participation in another clinical trial or treatment with certain drugs.
- History of severe heart or lung disease.
- Autoimmune diseases requiring treatment, except for certain stable conditions.
- Use of immunosuppressive medications recently or during the study.
- Active infections like HIV, hepatitis B or C, or tuberculosis.
- Recent major surgery or planning major surgery during the study.
- Pregnant or breastfeeding women.
- Other serious medical conditions that could interfere with the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Lifespan Cancer Institute: The Miriam and Rhode Island Hospitals Providence, Rhode Island, United States, 02903 Contact: | 02903 | Providence | Rhode Island |
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